Intervention Studies - Clinical Trials

Code:

PDICSS013_18

Acronym:

PDICSS013_18

Keywords
Classification	Keyword
OFICIAL	Health Sciences-Clinical and Health Serv. Research

Instance: 2023/2024 - 2S

Active?	Yes
Responsible unit:	Department of Community Medicine, Information and Health Decision Sciences
Course/CS Responsible:	PhD in Clinical and Health Services Research

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
PDICSS	18	Current Studies Plan	1	-	3	14	81

Teaching language

Suitable for English-speaking students

Objectives

Explain the definition and framework of intervention studies;

Characterize the design methodology of intervention studies;

Design clinical trials,

Implement clinical trials;

Interpret clinical trials results,

Assess clinical trials from the economic point of view;

Discuss the ethical and legal aspects to consider in the design and implementation of clinical trials;

Write clinical trials protocols and proposals;

Discuss the main difficulties of participating as researcher on clinical trials

Learning outcomes and competences

-

Working method

Presencial

Program

Intervention Studies – Definition and framing;

Clinical trial design, methodological aspects and structuring of clinical trials protocols - the recommendations SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials);

Regulation and legislation;

Introduction to the recommendations of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);

Good Clinical Practices;

Practical aspects in the implementation of a clinical trial;

Quality management;

Organizational, administrative and financial aspects;

Presentation of results of intervention trials – CONSORT recommendations (Consolidated Standards of Reporting Trials);

Clinical trials controversies .

Mandatory literature

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel grouprandomised trials, J Clin Epidemiol. 2010 Aug;63(8):e1-37
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. S; SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. , BMJ. 2013 Jan 8;346:e7586
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2). 11/2016.

Teaching methods and learning activities

After the theoretical exposition of each topic described for the curricular unit students will perform practical assignments in group, critical analysis and practical exercises. Individual study. The course will have its evaluations resulting mainly from the completion of a written test and presentation of a work.
Final score = 0.4 *  theory test + 0,4*work + 0.2 * classroom participation

Evaluation Type

Distributed evaluation without final exam

Assessment Components

Designation	Weight (%)
Participação presencial	20,00
Teste	40,00
Trabalho escrito	40,00
Total:	100,00

Amount of time allocated to each course unit

Designation	Time (hours)
Apresentação/discussão de um trabalho científico	2,00
Estudo autónomo	46,00
Frequência das aulas	13,00
Trabalho escrito	20,00
Total:	81,00

Eligibility for exams

active participation during sessions, submission of written assignment

Calculation formula of final grade

Final score = 0.4 *  theory test + 0,4*work + 0.2 * classroom participation